itcss
Director, Toxicology
Irvine, California, United States · Director
Sponsorship not specified$188k-$264kDetected 53 days ago
ComplianceProject ManagementBusiness DevelopmentRecruitingHRClinical TrialsPharmacologyFDA RegulatoryAnimal StudiesCommunicationCollaboration
About the role
- Subject Matter Expert in toxicology, safety pharmacology and nonclinical safety assessment across all Tarsus Programs
- Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance (GLP, animal welfare, and safety), and high-quality study interpretation
- Authoring and review of toxicology sections for regulatory submissions (IND, CTA, NDA/BLA, IBs and CSR)
Responsibilities
- Partner with key internal experts across the company including Innovation Lab and Business Development (BD) for asset evaluation and development strategies, identify toxicology risks and mitigation strategies
- Identify and implement innovative AI driven toxicology approaches including NAMs to support regulatory submission and interactions with regulatory agencies
- Collaboration and Team Building
- Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
- Demonstrates strong business acumen by anticipating market dynamics and using financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value.
- Establish and maintain strong external partnerships with CROs, academic institutions and key opinion leaders
- Define and drive GLP- safety /toxicology strategies across programs to accelerate programs to FIH
Requirements
- 12+ years in pharma or biopharma toxicology/pathology
- preference for individual with experience in ophthalmology.
- Experience managing outsourced studies
- must be able to provide succinct, strategic, and actionable insights.
- Some travel may be required - up to 20%
Nice to have
- PhD, MD/PhD, DVM, or related field in Toxicology, Pharmacology, Biology
- DABT or ERT certification preferred.
- Strong GLP and ICH guidance knowledge
- Experience with EMA/FDA CTA/IND submissions and regulatory interactions preferred.
Skills
- Your Human Resources Team
- Strong interpersonal skills, diplomacy, and positive-influencing abilities.
- Effective project management skills.
Compensation
- The expected base pay range for this position is $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits.
Benefits
- Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
- The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Company info
- We are passionate about our culture!
- Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
This listing is sourced directly from itcss's careers page and normalized into a canonical job model.